
Austenal Dental, Inc.
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A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) is an FDA 510(k)-cleared medical device (K864826) manufactured by Austenal Dental, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 1987. Regulation: 8.